Consumers Union: Hip, Knee Implants Should Come With Warranties

It may be tough to view a hip or knee replacement in the same light as a
car, appliance, or piece of expensive technology. In many cases, if one
of these items breaks or has a defect, a consumer can utilize a
contractual warranty to get some or all of their money back or even
replace the product at minimal cost.

Patients implanted with artificial knees or hips, however, have no such
options available in the event their implant should fail or be recalled.
One consumer activist group wants to change this by having implant
manufacturers stand by their products—in writing.

Through a new campaign called the “Safe Patient Project,”
Consumers Union, the group responsible for publishing Consumer
Reports, has suggested artificial hip and knee manufacturers offer
warranties on their products so that “consumers have clear actions to
take if their implants fail.”

“Patients have a right to know how long medical device manufacturers are
willing to stand by their products,” Lisa McGiffert, director of
Consumers Union’s Safe Patient Project, said in a press statement
published by the Consumerist. “While patients may be told by their
surgeon how long a device can be expected to last, they rarely get a
guarantee in writing since most hip and knee implants do not come with
warranty.”

If the Safe Patient Project is successful, hip and knee manufacturers
will have to stand by the quality of their products for at least 20
years, a number that may be frightening to some companies considering
the increasing number of worldwide recalls and baby boomers who may need
hip and knee replacements in the near future. By some experts’
estimates, the demand for hip and knee replacement surgeries could
surpass four million a year by 2030, with more than half of those
patients under 65 years old.

The sheer number—1.2 million surgeries in 2011 alone—and cost of
artificial hip and knee implant procedures and recalls in recent
years—as well as the hundreds of millions of dollars America’s
healthcare system spends on corrective surgeries—is staggering. On
average, according to a MinnPost article detailing the issue, the
average cost of hip and knee replacement surgeries is $19,000 and
$17,500, respectively, with half of those prices covering only the cost
of the implant itself. Corrective surgery, according to Consumers Union,
can average roughly $25,000. Those prices, when added to the costs
accumulated by the thousands of recalls issued by the six top-selling
hip and knee implant manufacturers over the past decade, the report
continues, create major financial burdens for both taxpayers and
patients.

Current regulations require medical device manufacturers to merely show
new products are similar to ones already on the market. Although
Congress attempted to create legislation that would mandate medical
device companies provide firm evidence that new products are safe and
effective before being granted federal approval, the industry blocked
the law from being passed. Because of this, according to MinnPost, more
than 90 percent of medical devices, including artificial knees and hips,
are cleared for sale without safety testing.

McGiffert feels, however, that if medical device manufacturers truly
feel their products pose no harm, then they should have no problem
putting it in writing.

“Medical device companies claim that current law provides adequate
protection for patients and that their implants are dependable and
safe,” McGiffert said. “If that’s the case, they should have no
objection to offering warranties to back up those claims. Patients and
taxpayers shouldn’t be on the hook for the cost of replacing devices
when they fail.”